Examining the Efficacy, Feasibility, and Acceptability of the DeST-ACT: Trauma-Focused Acceptance and Commitment Therapy Program on Life Satisfaction in Earthquake Survivors
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Engaged Living Scale
研究概览
简要总结
The aim of this study is to develop a post-earthquake, trauma-focused Acceptance and Commitment Therapy (ACT)-based psychosocial intervention program (DeST-ACT) and to examine its effectiveness, feasibility, and acceptability of this program in enhancing life satisfaction and psychological flexibility in individuals exposed to earthquake trauma.
In this regard, the main hypothesis is that the DeST-ACT psychosocial intervention program is effective, feasible, and acceptable among individuals exposed to earthquake trauma, including both primary and secondary outcomes of the program.
详细描述
This quantitative, randomized controlled trial involves two groups and includes a pre-test and repeated post-tests. The study aims to assess the effectiveness, feasibility, and acceptability of the developed DeST-ACT program in addressing post-traumatic stress disorder, psychological flexibility, life satisfaction, values-based living, and depression-anxiety-stress levels in individuals affected by the February 6, 2023 earthquake. Participants will be randomly assigned to experimental and control groups in a 1:1 ratio using an internet-based block randomization program.
The DeST-ACT psychosocial intervention program consists of a 4-session online intervention supported by self-help materials. Each session in the 4-week program is held once a week for 50 minutes.
The main hypotheses are:
- The intervention group will demonstrate a significant decrease in Post Traumatic Stress Disorder (PTSD) and depression-anxiety-stress levels compared to the control group.
- The intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to the control group.
- The intervention group will demonstrate a significant decrease in PTSD and depression-anxiety-stress levels compared to baseline measures.
- The intervention group will experience a greater increase in values-based living, life satisfaction, and psychological flexibility over time compared to baseline measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will be conducted by a research assistant using an internet-based program following the pre-test. The pre-test and post-tests will be administered by a different researcher who is blinded to the study. The therapy program will be conducted by independent therapists who are also blinded to the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteering to participate in the research
- •Being present in cities such as Kahramanmaras, Gaziantep, Hatay, Adiyaman, or Malatya during the earthquake on February 6, where destruction occurred
- •Being literate
- •Being able to have an online interview with the therapist
- •Having sub-threshold PTSD or PTSD
排除标准
- •Being in other cities at the time of the earthquake and not being exposed to the earthquake
- •Having visual and/or hearing problems
- •Having any psychotic disorder, experiencing an active mood episode, or having conditions such as intellectual disability or dementia that would prevent participation in therapy
- •Starting a new psychiatric treatment during the research period or having a change in medication or dosage within the last 3 months.
结局指标
主要结局
Engaged Living Scale
时间窗: At baseline, after 4 weeks, after 8 weeks
The Engaged Living Scale is designed to evaluate values-based living. It consists of 16 items rated on a 5-point Likert scale, ranging from 1 (Totally Agree) to 5 (Totally Disagree), with scores ranging from a minimum of 16 to a maximum of 80. The scale, for which Turkish validity and reliability studies have been conducted, has two sub-dimensions: "valued living" and "life fulfillment." The Cronbach's alpha value for the Turkish version of the scale is 0.91, with 0.87 for the valued living sub-dimension and 0.86 for the life fulfillment sub-dimension.
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5)
时间窗: At baseline, after 4 weeks, after 8 weeks
The PCL-5 was developed based on the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders-5, and its aim is to evaluate PTSD symptoms. The scale consists of 20 items rated on a 5-point Likert scale. Scores above 47 are indicative of PTSD.
Depression Anxiety and Stress Scale 21 (DASS-21)
时间窗: At baseline, after 4 weeks, after 8 weeks
The DASS-21 measures the dimensions of depression, stress, and anxiety. The scale consists of 21 items rated on a 4-point Likert scale ranging from 0 (Never) to 4 (Always) with scores ranging from a minimum of 0 to a maximum of 84. The Cronbach's alpha values for the scale, based on Turkish validity and reliability studies, are 0.80 for anxiety, 0.82 for depression, and 0.75 for stress.
次要结局
- Acceptance and Action Questionnaire-2 (AAQ-2)(At baseline, after 4 weeks, after 8 weeks)
- Therapy Satisfaction Questionnaire(after 4 week)
- Drop Rate(after 8 weeks)
研究者
Sevinc Ulusoy
Principal Investigator
CanSagligi Foundation